Evaluating the effects of dapagliflozin on kidney function in advanced chronic kidney disease
Effects of Sodium-Glucose Cotransporter 2 Inhibitors on Kidney Function in Advanced Chronic Kidney Disease
PHASE3 · Ain Shams University · NCT06982079
This study is testing if the medication dapagliflozin can help slow down kidney problems and lower the risk of heart or kidney-related deaths in adults with advanced chronic kidney disease.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ain Shams University (other) |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06982079 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess whether dapagliflozin can slow the decline of kidney function and reduce the risk of death from cardiovascular or renal causes in adults with advanced chronic kidney disease (CKD), with or without type 2 diabetes. Participants will be randomly assigned to receive either dapagliflozin or a placebo, allowing researchers to compare the outcomes related to kidney and cardiovascular health. The study focuses on a high-risk population that has been largely excluded from previous major trials, addressing a significant gap in current treatment guidelines for patients with severe CKD.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 or older with advanced chronic kidney disease (eGFR < 20 mL/min/1.73m²) who are not on dialysis.
Not a fit: Patients with autosomal dominant polycystic kidney disease, type 1 diabetes, or those currently taking SGLT2 inhibitors may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could provide a new treatment option that significantly improves kidney and cardiovascular outcomes for patients with advanced CKD.
How similar studies have performed: While SGLT2 inhibitors have shown promise in other populations, this specific approach in patients with advanced CKD is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients aged eighteen or older. * Patients with advanced chronic kidney disease (i.e., eGFR \< 20 mL/min/1.73m2)not on dialysis Exclusion Criteria: * Autosomal dominant polycystic kidney disease (ADPKD). * Type 1 diabetes mellitus * Patients on SGLT2 inhibitors. * History of ketoacidosis in the last 3 months. * Known hypersensitivity to SGLT2 inhibitors. * Known hepatic impairment. * Pregnant or breastfeeding females.
Where this trial is running
Cairo
- Ain Shams University Hospitals — Cairo, Egypt (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Kidney Disease Stage 5, CKD Stage 4